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Title: Standardized classification and framework for reporting, interpreting, and analysing medication non-adherence in cardiovascular clinical trials: a consensus report from the Non-adherence Academic Research Consortium (NARC)
Authors: Valgimigli, Marco
Garcia-Garcia, Hector M.
Vrijens, Bernard
Vranckx, Pascal 
McFadden, Eugene P.
Costa, Francesco
Pieper, Karen
Vock, David M.
Zhang, Min
Van Es, Gerrit-Anne
Tricoci, Pierluigi
Baber, Usman
Steg, Gabriel
Montalescot, Gilles
Angiolillo, Dominick J.
Serruys, Patrick W.
Farb, Andrew
Windecker, Stephan
Kastrati, Adnan
Colombo, Antonio
Feres, Fausto
Juni, Peter
Stone, Gregg W.
Bhatt, Deepak L.
Mehran, Roxana
Tijssen, Jan G. P.
Issue Date: 2019
Source: EUROPEAN HEART JOURNAL, 40(25), p. 2070-2085
Abstract: Non-adherence has been well recognized for years to be a common issue that significantly impacts clinical outcomes and health care costs. Medication adherence is remarkably low even in the controlled environment of clinical trials where it has potentially complex major implications. Collection of non-adherence data diverge markedly among cardiovascular randomized trials and, even where collected, is rarely incorporated in the statistical analysis to test the consistency of the primary endpoint(s). The imprecision introduced by the inconsistent assessment of non-adherence in clinical trials might confound the estimate of the calculated efficacy of the study drug. Hence, clinical trials may not accurately answer the scientific question posed by regulators, who seek an accurate estimate of the true efficacy and safety of treatment, or the question posed by payers, who want a reliable estimate of the effectiveness of treatment in the marketplace after approval. The Non-adherence Academic Research Consortium is a collaboration among leading academic research organizations, representatives from the U.S. Food and Drug Administration and physician-scientists from the USA and Europe. One in-person meeting was held in Madrid, Spain, culminating in a document describing consensus recommendations for reporting, collecting, and analysing adherence endpoints across clinical trials. The adoption of these recommendations will afford robustness and consistency in the comparative safety and effectiveness evaluation of investigational drugs from early development to post-marketing approval studies. These principles may be useful for regulatory assessment, as well as for monitoring local and regional outcomes to guide quality improvement initiatives.
Notes: [Valgimigli, Marco; Costa, Francesco; Windecker, Stephan] Bern Univ Hosp, Swiss Cardiovasc Ctr Bern, Dept Cardiol, Bern, Switzerland. [Garcia-Garcia, Hector M.] MedStar Washington Hosp Ctr, Intervent Cardiol Dept, Washington, DC USA. [Vrijens, Bernard] Univ Liege, Dept Biostat, Liege, Wallonia, Belgium. [Vranckx, Pascal] Jessa Ziekenhuis, Hartctr Hasselt, Dept Cardiol & Crit Care Med, Hasselt, Belgium. [Vranckx, Pascal] Hasselt Univ, Fac Med & Life Sci, Hasselt, Belgium. [McFadden, Eugene P.] Cork Univ Hosp, Dept Cardiol, Cork, Ireland. [Costa, Francesco] Univ Messina, Policlin G Martino, Dept Clin & Expt Med, Messina, Italy. [Pieper, Karen; Tricoci, Pierluigi] Duke Univ, Med Ctr, Duke Clin Res Inst, Durham, NC USA. [Vock, David M.] Univ Minnesota, Div Biostat, Minneapolis, MN USA. [Zhang, Min] Univ Michigan, Sch Publ Hlth, Dept Biostat, Ann Arbor, MI 48109 USA. [Van Es, Gerrit-Anne; Tijssen, Jan G. P.] European Cardiovasc Res Inst, Rotterdam, Netherlands. [Baber, Usman] Icahn Sch Med Mt Sinai, Div Cardiol, New York, NY 10029 USA. [Steg, Gabriel] Hop Xavier Bichat, AP HP, Dept Cardiol, Paris, France. [Montalescot, Gilles] CHU Pitie Salpetriere, Inst Cardiol, Paris, France. [Angiolillo, Dominick J.] Univ Florida, Coll Med, Div Cardiol, Jacksonville, FL USA. [Serruys, Patrick W.] Imperial Coll London, NHLI, Int Ctr Circulatory Hlth, London, England. [Farb, Andrew] US FDA, Div Cardiovasc & Renal Prod, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA. [Kastrati, Adnan] Tech Univ Munich, Deutsch Herzzentrum Munchen, Munich, Germany. [Colombo, Antonio] Ist Sci San Raffaele, Intervent Cardiol Dept, Milan, Italy. [Colombo, Antonio] EMO GVM Ctr Cuore Columbus, Intervent Cardiol Dept, Milan, Italy. [Feres, Fausto] Ist Dante Pazzanese Cardiol, Div Cardiol, Sao Paulo, Brazil. [Juni, Peter] Inst Primary Hlth Care, Toronto, ON, Canada. [Stone, Gregg W.] Columbia Univ, Med Ctr, New York Presbyterian Hosp, New York, NY USA. [Stone, Gregg W.] Cardiovasc Res Fdn, New York, NY USA. [Bhatt, Deepak L.] Brigham & Womens Hosp, Heart & Vasc Ctr, 75 Francis St, Boston, MA 02115 USA. [Bhatt, Deepak L.] Harvard Med Sch, Boston, MA 02115 USA. [Tijssen, Jan G. P.] Univ Amsterdam, Acad Med Ctr, Amsterdam, Netherlands.
Keywords: Adherence; Compliance; Persistence; Clinical trial; Medication;Adherence; Compliance; Persistence; Clinical trial; Medication
Document URI:
ISSN: 0195-668X
e-ISSN: 1522-9645
DOI: 10.1093/eurheartj/ehy377
ISI #: 000490138100017
Rights: The Author(s) 2018. For permissions, please email:
Category: A1
Type: Journal Contribution
Validations: ecoom 2020
Appears in Collections:Research publications

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